Revised: March 2013

AN. 01383/2011

SUMMARY OF PRODUCT CHARACTERISTICS

1)

NAME OF THE VETERINARY MEDICINAL PRODUCT

Vitamin K1 Laboratoire TVM, Solution for injection for dogs, 10 mg/ml (for UK, IT, D, AT,
NL)
Vitamina K1 Laboratoire TVM, Solution for injection for dogs, 10 mg/ml (for ES)
Vitamine K1 injectable TVM, Solution for injection for dogs, 10 mg/ml (for FR)
2)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1ml contains:
Active substance:
Phytomenadione

10,0 mg

For full list of excipients, see section 6.1.

3)

PHARMACEUTICAL FORM

Solution for injection

Yellow, clear to slightly opalescent liquid.
4)

CLINICAL PARTICULARS:
4.1 - Target species

Dogs
4.2 - Indications for use, specifying the target species
In dogs:
Emergency treatment of anticoagulant rodenticide poisoning, before starting oral
treatment.
4.3 - Contraindications
Do not use in cases of known hypersensitivity to the active substance or to any of the
excipients.
4.4 - Special warnings for each target species
As the anticoagulant effects of rodenticides are known to be long lasting it is
recommended to start vitamin K1 supplementation with an oral formulation within 12
hours of the last injection for a duration of 3 weeks, and to evaluate the coagulation
status (via one stage prothrombin times) 48 hours after the last administration. In the
case of persistence of the anticoagulant in the body, the duration of treatment can be
extended as long as the anticoagulant persists, to avoid relapse (the coagulation status
has to be evaluated 48 hours after each attempt of treatment cessation).
4.5 - Special precautions for use
i.
Special precautions for use in animals
The product should be administered only by veterinarian.
Administer by slow intravenous injection.
The formation of prothrombin may be inadequate when dealing with patients with
severe liver dysfunction. Therefore requires a careful monitoring of coagulation
parameters after administration of vitamin K1.

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ii.

Special precautions to be taken by the person administering the

medicinal product to animals
People with known hypersensitivity to phytomenadione should avoid contact with the
veterinary medicinal product.
Avoid contact with eye. In the event of accidental contact with eye, rinse immediately
and thoroughly with tap water, then seek a doctor and show the label to the physician.
In case of accidental self-injection, seek medical advice immediately and show the
package leaflet or the label to the physician.

iii.

Other precautions
None.
4.2 - Adverse reactions (frequency and seriousness)
Some cases of hypersensitivity reactions (anaphylactic-type reactions) have been
described.
4.3 - Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established in bitch during
pregnancy and lactation.
Studies conducted in laboratory animals have shown no teratogenic or ftotoxic
effects. Vitamin K1 crosses the placental barrier.
Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
4.4 - Interaction with other medicinal products and other forms of
interaction
Salicylates (NSAID) and cephalosporins presenting the N-methyl-thiotetrazole moiety
may reduce the effect of vitamin K1, by inhibition of the vitamin K1 recycling.
4.5 - Amounts to be administered and administration route
Slow intravenous injection of 5 mg vitamin K1 per kg bodyweight (equivalent to 0.5 ml of
the product per kg bodyweight) prior to commencing oral therapy (see section 4.4).
Treatment by injection should be repeated once 12-18 hours later if oral treatment is
not immediately possible.
4.6 - Overdose (symptoms, emergency procedures, antidotes), if necessary
Vomiting has been observed in the dog after the 1 st and the 2nd injections, administered
12 hours apart at 3 times the recommended dose (15 mg of vitamin K 1 per kg of body
weight per injection).
Repeating dosing (10 days) at 7 times the recommended dose of a degraded solution
(degradation of lecithin into lysolecithin is observed with time during the storage of the
product) caused intravascular haemolysis, involving marked anaemia and vomiting.
4.7 - Withdrawal period
Not applicable.
5)

PHARMACOLOGICAL PROPERTIES:

ATC Vet code: QB02BA01

Pharmacotherapeutic classification: antihemorrhagic
5.1 - Pharmacodynamic properties
Vitamin K1 is a cofactor necessary for the synthesis of K-dependent coagulation factors
(factors II, VII, IX and X). During this synthesis, vitamin K 1 is converted into vitamin K1
hydroquinone (active form of vitamin K1) and then into vitamin K1 epoxide. It is then
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recycled back into vitamin K1. Antivitamin K rodenticides inhibit the recycling of vitamin
K1 epoxide, causing a risk of uncontrolled bleeding through the absence of functional
factors II, VII, IX and X synthesis. The supply of vitamin K 1 must be sufficiently large to
activate hydrogenase enzyme that converts it to its active (hydroquinone) form.
5.2 - Pharmacokinetics particulars
After intravenous administration at 5 mg/kg in the dog, the following pharmacokinetic
parameters were obtained:
Cmax = 85.2 g/ml, AUC = 4246 g.min./ml, T1/2 = 179.5 min., Cl = 1.15 ml/min., a
bioavailability of 100 % and a distribution volume estimated at 4 10 -4 ml.
One hour after intravenous administration, vitamin K1 is detected in the liver (90%
unchanged) before being distributed throughout the body.
Some of the vitamin K1 is eliminated with the bile in the intestinal tract after metabolism
in the liver, and some is eliminated in urine (in the form of glucuronoconjugated
metabolites).
6)

PHARMACEUTICAL PARTICULARS

6.1 - List of excipients

Glycocholic acid
Lecithin (soya bean)
Sodium hydroxide
Hydrochloric acid
Water for injections
6.2 - Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be
mixed with other veterinary medicinal products.
6.3 - Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sales: 3 years.
Use immediately after opening.
6.4 - Special precautions for storage
Protect from light.
Store below 25C.
Any solution remaining in the ampoule following withdrawal of the required dose should
be discarded.
6.5 - Nature and composition of immediate packaging
5ml amber clear glass ampoules, type I.
6.6 - Special precautions for the disposal of unused veterinary medicinal
product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such
veterinary medicinal product should be disposed of in accordance with local
requirements.

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7)

MARKETING AUTHORISATION HOLDER

Laboratoire TVM
57 rue des Bardines
63370 LEMPDES
France
8)
MARKETING AUTHORISATION NUMBER
Vm 35079/4000
9)
DATE OF FIRST MARKETING AUTHORISATION
20 April 2010
10)
DATE OF REVISION OF THE TEXT
March 2013

Approved:

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27/03/2013